meddevicedb.com FDA Device Reference

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

DEN120014 Class II Post-NSE
Decision Date
2012-06-26
Sponsor / Applicant
Nanosphere, Inc.

Technical Specification

510(k) Submission ID DEN120014
Product Code PAM
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.3365
Decision Date 2012-06-26
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) received FDA 510(k) clearance under submission number DEN120014, sponsored by Nanosphere, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2012-06-26.

Classification & Regulation

This clearance is catalogued under FDA product code PAM and 21 CFR 866.3365, within the Microbiology review panel as a Class II device.